Pharmaceutical Process Validation: Emplication of New FDA Guidelines
Capability of a process: Ability of a process to produce a product that will fulfill the requirements of that product. The concept of process capability can also be defined in statistical terms. (ISO 9000:2005)
Commercial manufacturing process: The manufacturing process resulting in commercial product (i.e., drug that is marketed, distributed, and sold or intended to be sold). For the purposes of this guidance, the term commercial manufacturing process does not include clinical trial or treatment IND material.
Concurrent release: Releasing for distribution a lot of finished product, manufactured following a qualification protocol, that meets the lot release criteria established in the protocol, but before the entire study protocol has been executed.
Continued process verification: Assuring that during routine production the process remains in a state of control.
Performance indicators: Measurable values used to quantify quality objectives to reflect the performance of an organization, process or system, also known as performance metrics in some regions.
Process design: Defining the commercial manufacturing process based on knowledge gained through development and scale-up activities.
Process qualification: Confirming that the manufacturing process as designed is capable of reproducible commercial manufacturing.
Process validation: The collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality products.
Quality: The degree to which a set of inherent properties of a product, system, or process fulfils requirements.
State of control: A condition in which the set of controls consistently provides assurance of continued process performance and product quality.
1. Prof. Podtar M.A.(2009) Pharmaceutical validation.Current good manufacturing practiceses,pp 413-414.
2. Biotechnology and regulatory legislation of FDA, its guidelines on gmp of pharmaceuticals, finalsafiapro2.pdf, accessed date was-20-12-2011
7. White paper, FDA Guidence for industry update – Process Validation: General Principles and Practices January 2011, @2009 pharmQut pyt Ltd, version 01,accessed date was -20-dec-2011,
8. FDA Guideline on General Principles of Process Validation – May 1987. White paper, FDA Guidence for industry update – Process Validation: General Principles and Practices January 2011, @2009 pharmQut pyt Ltd, version 01,accessed date was -20-dec-2011,
11. New-Rx-protocol.pdf.2011accessed date was-24-12-2011,
15. Guidance for Industry,process validation:General principles and practices, available through website fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm and fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm and fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm Accessed on date-5-dec-2011.
16. Saudi Food & Drug Authority 2010 Guidelines for Process Validation of Pharmaceutical Dosage Forms Version 2,available through website sfda.gov.sa/En/DrugAccessed on date-20/dec/2011.
17. Nash A. Robert Wachter H. Alfred “Pharmaceutical process validation” volume 129, 3rd edition, digital edition,ISBN: 0-8247-0838-5 HeadquartersMarcel Dekker, Inc.,270 Madison Avenue, New York, NY 10016 accessed on the date -20-dec-2011
18. Communications Staff, HFV-12, Center for Veterinary Medicine, Food and Drug Administration, fda.gov/cvm/guidance/published.htmlGuidance for Industry “Quality Systems Approach to Pharmaceutical CGMP Regulations” accessed date was-20-dec-2011.
19. G. Arjun, N. V. Anil Kumar Ravipati, D.Satish kumar et al,Industrial process validation of solid dosage form – AN OVERVIEW,ISSN 0976 – 044X, Volume 4, Issue 2, September – October 2010; Article 025, accessed date 20 12 2011
20. Analytical Procedures and Methods ValidationOffice of Training and Communications, Division of Communications Management, Drug Information Branch, HFD-210, Center for Drug Evaluation and Research (CDER),accessed date-20-dec-2011, available at fda.gov/cder/guidance/index.htm
21. Regulatory guidance 2008 PREPARATION OF VALIDATION MASTER PLAN, HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP, accessed date-20-dec-2011.
22. Randall Schadt, Ph.D. Pfizer Global Manufacturing, Pfizer Inc.Process Analytical Technology – Changing the Validation Paradigm,accessed date was-20-dec-2011 available at americanpharmaceuticalreview.com/article.asp?articleid=28
23. Guidance for Industry and FDA Staff “Medical Glove Guidance Manual”, Accessed date was -20-dec-2011, Available at fda.gov/cdrh/ocer/guidance/1661.html.
24. Gillian C-L, Roger A, Anik Egan, et al. “A WHO guide to good manufacturing practice (GMP) requirements,Part 1: Standard operating procedures andmaster formulae” World Health Organization Geneva 1997, accessed date -20-dec-2011.
Other suggesting sites
17. spectorpr.com/blog/2012/01/25/new-developments-pharmafda-faceoff theclarkfirmtexas.com/dietary-supplement-guidelines-inadequate
NOW YOU CAN ALSO PUBLISH YOUR ARTICLE ONLINE.
SUBMIT YOUR ARTICLE/PROJECT AT firstname.lastname@example.org
FIND OUT MORE ARTICLES AT OUR DATABASE